Hepatitis CPhase 1NCT00904059
Drug-Drug Interaction Study in Healthy Subjects
A Phase 1 study testing BMS-650032 and BMS-790052 in people with Hepatitis C, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- BMS-650032 and BMS-790052
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged 18 to 49 years
- Females who are not of childbearing potential, pregnant or breastfeeding
- Subject Body Mass Index (BMI) of 18 to 32 kg/m²
Who cannot join
- Women of child bearing potential
- Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Prior exposure to BMS-650032 or BMS-790052
- Positive for HIV or HCV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Randomized, Multiple-Dose, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of BMS-790052 and BMS-650032 Co-administered in Healthy Subjects
The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone
Read the detailed description
Pharmacokinetics and Safety in Healthy Subjects
- Conditions
- Hepatitis C
- Being tested
- BMS-650032, BMS-790052
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-650032Drug
Capsules, Oral, 600 mg, Q12h, Days 1-7
BMS-790052Drug
Capsules, Oral, 60 mg, Q24h, Days 1-7
BMS-650032Drug
Capsules, Oral, 200 mg, Q12h, Days 8-21
BMS-790052Drug
Capsules, Oral, 30 mg, Q24h, Days 8-21
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | Not described Receives: Drug: BMS-650032 |
| Treatment Group B | Experimental | Not described Receives: Drug: BMS-790052 |
| Treatment Group C | Experimental | Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg) Receives: Drug: BMS-650032; Drug: BMS-790052 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin
Measured: Day 21 pharmacokinetic assessment
Secondary outcomes (1)
To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered
Measured: Within 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904059
- Sponsor's protocol ID
- AI447-009
- Status last verified
- Dec 2010
- First submitted
- 21 Apr 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Multiple-Dose, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of BMS-790052 and BMS-650032 Co-administered in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00904059
- Acronym / sponsor ID
- AI447-009
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone
Detailed description
Pharmacokinetics and Safety in Healthy Subjects
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: BMS-650032 |
| Treatment Group B | Experimental | Drug: BMS-790052 |
| Treatment Group C | Experimental | Drug: BMS-650032, Drug: BMS-790052Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects aged 18 to 49 years
- Females who are not of childbearing potential, pregnant or breastfeeding
- Subject Body Mass Index (BMI) of 18 to 32 kg/m²
Key exclusion criteria (6 listed)
- Women of child bearing potential
- Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Prior exposure to BMS-650032 or BMS-790052
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-650032Capsules, Oral, 600 mg, Q12h, Days 1-7 | Drug | Treatment Group A |
| BMS-790052Capsules, Oral, 60 mg, Q24h, Days 1-7 | Drug | Treatment Group B |
| BMS-650032Capsules, Oral, 200 mg, Q12h, Days 8-21 | Drug | Treatment Group C |
| BMS-790052Capsules, Oral, 30 mg, Q24h, Days 8-21 | Drug | Treatment Group C |
Primary outcome
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin
Time frame: Day 21 pharmacokinetic assessment
1 secondary outcome
To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered
Time frame: Within 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-650032 and BMS-790052 in people with Hepatitis C, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin (time frame: Day 21 pharmacokinetic assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2011.